Use of read-across and computer-based predictive analysis for the safety assessment of PEG cocamines

Skare, Julie A.; Blackburn, Karen; Wu, Shengde; Re, Thomas; Duché, Daniel; Ringeissen, Stéphanie; Bjerke, Donald L.; Srinivasan, Viny; Eisenmann, Carol J.

doi:10.1016/j.yrtph.2015.01.013

Cited by 8 publications

(7 citation statements)

References 13 publications

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“…The framework for identifying and evaluating analogs applied in this safety assessment is described and explained in several publications, 3,7,36,38 including one paper that illustrates the application of the framework for assessing the safety of the PEGs cocamine ingredients that are specifically derivatives of coconut oil. 7 The read-across analysis evaluated by the Panel covers the entire group of PEGs cocamine and related ingredients, including the derivatives of soy and rapeseed oil and tallow and the other fatty acids from which the ingredients of this group are manufactured.…”

Section: Application Of the Framework To Evaluate Pegs Cocamine Ingrementioning

confidence: 99%

“…Oxidative N-dealkylation (also known as deamination) involves hydrogen abstraction and oxygen addition (hydroxylation) at a carbon atom a to the nitrogen atom. The further metabolic oxidation of aldehydes (6) and (8) results in carboxylic acids (7) and (10).…”

Section: Metabolismmentioning

confidence: 99%

“…6 The application of the framework to the PEGs cocamine ingredients (specifically the derivatives of coconut oil) was published in March 2015. 7 The read-across analysis presented in the CIR SSC submissions, 4,5 Dr Blackburn's presentation to the Panel, 6 and the March 2015 publication 7 indicate that these ingredients will not exhibit genotoxicity or systemic toxicity when used as intended in cosmetics. In addition, the CIR SSC's submissions and the March 2015 publication included computational analyses, indicating that the PEGs cocamine, like the PEGs, are not dermal sensitizers.…”

Section: Introductionmentioning

confidence: 99%

“…In addition, the CIR SSC's submissions and the March 2015 publication included computational analyses, indicating that the PEGs cocamine, like the PEGs, are not dermal sensitizers. 4,5,7,8 This safety assessment presents data and analyses from multiple sources, including the Council and the CIR SSC, to facilitate assessing the safety of the PEGs cocamine and related ingredients. The information submitted by the Council and the CIR SSC 4,5 included toxicological data from 2 US Environmental Protection Agency (EPA) high-production volume (HPV) chemicals challenge reports 9,10 and 3 unpublished reports cited in one of the HPV reports.…”

Section: Introductionmentioning

confidence: 99%

“…6 The application of the framework to the PEGs cocamine ingredients (specifically the derivatives of coconut oil) was published in March 2015. 7…”

Section: Introductionmentioning

confidence: 99%

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Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics

Boyer¹,

Burnett²,

Bergfeld³

et al. 2018

Int J Toxicol

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The Cosmetic Ingredient Review Expert Panel assessed the safety of 47 polyethylene glycols (PEGs) cocamine and related ingredients, which are reported to function mostly as surfactants and antistatic agents. The Panel reviewed the relevant data and developed a framework to satisfy previously identified data deficiencies for this group of materials as well as extend the scope of related materials covered by the analysis. The irritation potential of these ingredients is consistent with the surface active properties that are characteristic of surfactants. The Panel concluded that the PEGs cocamine and related ingredients were safe as ingredients in cosmetic formulations in the current practices of use and concentration when formulated to be nonirritating.

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